Tech Transfer Lead Senior 29326A
JobTitle: Tech Transfer Lead Senior 29326A
About Company: Our client based in Dun Laoghaire is seeking a Tech Transfer Lead Senior 29326A to join its expanding team.
Duration of Role: 12 months
Summary Objective: Leads new product introductions to ADL PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer to PM2 or PM3.
• Development of validation plans, process performance qualifications for vial and syringe filling.
• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
• Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
• Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
• Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
• Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
• Act as the responsible point contact from ADL site for the transfer project for drug product teams and Global Operations Teams.
• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
• Collate and report on relevant shipping and filter validation.
• Assist in deviation and exception resolution and root cause analysis.
• Contribute to product quality assessments and process flow documents.
Skills and requirements
•Third level Bachelor’s degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience.
•Knowledge of cGMPs and other worldwide regulatory requirements.
•Doctorate or Masters in Science or Engineering.
•5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
•Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
•Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
•Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
Benefits of working with Independent Solutions
Benefit from Independent Solutions ethical principles!
We look after our team, we know the business, we have been working in the sector >20 years. We are not a recruitment agency
While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross functional LifeScience team
We offer attractive rates – competitive margins compared to our competitors.
Payment on time and in full
We continue to partner and grow our client base and thereby ensure that we have continuous supply of High-Value Projects
We work for you !
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Tel: +353 1 5311 280
Fax: +353 1 5311 285